Early in January, the Department of Health and Human Services (HHS) released the draft Trusted Exchange Framework, as required by the 21st Century Cures Act of 2016. Specifically, Congress directed ONC (the Office of the National Coordinator for Health IT) in the legislation to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.”

The draft Trusted Exchange Framework, released on Jan. 5, 2018, outlines a common set of principles for trusted exchange and minimum terms and conditions for trusted exchange. This is designed to bridge the gap between providers’ and patients’ information systems and enable interoperability across disparate health information networks (HINs), according to ONC officials. What’s more, the TEFCA will be facilitated through ONC in collaboration with a single recognized coordinating entity (RCE).

This week, Jeff Coughlin, senior director, federal and state affairs, HIMSS (the Healthcare Information and Management Systems Society), noted what while TEFCA provides the community with guidance on the policies, procedures and technical standards that participants could use to be more interoperable, the process hinges on finding a qualified RCE, which ONC has said will be selected in a competitive application process and which will develop a single Common Agreement that qualified health information networks (HINs) and their participants will voluntarily agree to adopt.

Coughlin wrote, “Most likely, market forces will compel HINs to want to become qualified HINs and abide by the principles and procedures outlined in TEFCA. However, it’s unclear what enforcement mechanisms exist to keep HINs aligned with the TEFCA guidance.”

Coughlin also wrote that when ONC proposes its information blocking provisions, as required by the Cures Act as well, “that when married to TEFCA, [it] should provide the substance needed to promote greater data exchange—along with a firm enforcement mechanism to ensure compliance. 21st Century Cures included civil monetary penalties up to $1 million per violation for networks, developers, or exchanges that block information,” he said.

What’s more, Coughlin said that before a single on-ramp interoperability concept is fully functional, HIN participation agreements will need to be worked out—specifically how they are currently constituted versus what they need to become in this new TEFCA infrastructure. “I think that the community needs to consider the impact of updating participation agreements when evaluating TEFCA. There could be significant additional levels of complexity, time and costs for updating/revising participation agreements,” he said.

He added that when qualified HINs “have varying, allowable permitted purposes in their own participation agreements, exchange between those qualified HINs is limited and may not occur—and could prevent end-users from having a single on-ramp to interoperability.” He continued, “If the market moves in the direction that ONC is intending and only a small number of qualified HINs (~10) come into existence, there will be a lot of work that has to occur to update these agreements across the entire community.”

Regarding costs, Coughlin wrote that the question around who pays for TEFCA implementation and execution and how much they pay also needs to be taken into consideration. Right now, ONC’s approach is to let the market sort out how much providers, vendors, payers and other end users will have to pay to participate. “My concern is that the expanded responsibilities of qualified HINs will lead to multiplied required costs and that those costs have to be passed down to providers and ultimately to patients,” he said.

Meanwhile, Healthcare Informatics’ Senior Contributing Editor David Raths brought up in a recent article the issue of what TEFCA might mean for the future of regional health information exchanges (HIEs). Raths quoted ONC’s Genevieve Morris, principal deputy national coordinator for health information technology, who spoke in a webinar and noted that regional HIEs have had trouble connecting providers in the ambulatory space. Said Morris, "My experience is that it takes six to nine months to connect one ambulatory practice. We would never get to nationwide interoperability within 100 years that way. While we have a number of regional HIEs that are doing very well, the amount of white space that has no coverage from a regional HIE is quite significant. As ONC, we have to be concerned about nationwide interoperability above everything else."

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